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Teva Pharmaceuticals
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Quality Analyst I

Quality Analyst I

Teva Pharmaceuticals

3 - 7 years

0 Lacs

navi mumbai all india

Posted:2 days ago| Platform: Shine logo

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Skills Required

quality assurance audit gcp glp sops bioanalytical clinical study biostatistics regulatory inspections lcmsms vendor audits calibration records

Work Mode

On-site

Job Type

Full Time

Job Description

Role Overview: As a Quality Analyst I at Teva Pharmaceuticals, your main responsibility will be to audit each BA/BE study (both pre and post study) to ensure conformance with relevant GCP/applicable GLP guidelines, protocols, and SOPs. You will also review SOPs, forms, formats, and logbooks of all departments, provide feedback, and prepare audit reports to ensure compliance and adherence to guidelines and procedures. Key Responsibilities: - Audit each BA/BE study to assure conformance with GCP/applicable GLP guidelines, protocols, and SOPs - Review SOPs, forms, formats, and logbooks of all departments and provide comments - Review change control and deviations as assigned - Prepare audit reports to ensure compliance with guidelines and regulatory inspections - Conduct in-process study audits to ensure compliance with GCP/GLP, protocols, SOPs, and regulatory requirements - Audit generated raw data, validation reports, bioanalytical reports, and clinical study outputs - Share QA audited concentration data with Biostatistician - Audit PK and statistical output of clinical studies - Audit Bio-summary tables, eCTD compilation of clinical studies - Review ongoing studies, reports, and documentation and release study-specific audit certificates - Co-ordinate with user departments and medical writers for finalization of reports - Conduct area-specific audits, system audits, and vendor audits as assigned - Audit calibration records/qualification records of instruments/equipment for bioanalytical as assigned - Control and issue documents for all departments of WPPL Qualifications Required: - B.Pharm, M.Pharm, or M.Sc - 3-6 years of experience in Bioanalytical Quality Assurance for a BA/BE Study Please note that the job posting also provides information about Teva Pharmaceuticals' mission and its commitment to making good health more affordable and accessible worldwide. Role Overview: As a Quality Analyst I at Teva Pharmaceuticals, your main responsibility will be to audit each BA/BE study (both pre and post study) to ensure conformance with relevant GCP/applicable GLP guidelines, protocols, and SOPs. You will also review SOPs, forms, formats, and logbooks of all departments, provide feedback, and prepare audit reports to ensure compliance and adherence to guidelines and procedures. Key Responsibilities: - Audit each BA/BE study to assure conformance with GCP/applicable GLP guidelines, protocols, and SOPs - Review SOPs, forms, formats, and logbooks of all departments and provide comments - Review change control and deviations as assigned - Prepare audit reports to ensure compliance with guidelines and regulatory inspections - Conduct in-process study audits to ensure compliance with GCP/GLP, protocols, SOPs, and regulatory requirements - Audit generated raw data, validation reports, bioanalytical reports, and clinical study outputs - Share QA audited concentration data with Biostatistician - Audit PK and statistical output of clinical studies - Audit Bio-summary tables, eCTD compilation of clinical studies - Review ongoing studies, reports, and documentation and release study-specific audit certificates - Co-ordinate with user departments and medical writers for finalization of reports - Conduct area-specific audits, system audits, and vendor audits as assigned - Audit calibration records/qualification records of instruments/equipment for bioanalytical as assigned - Control and issue documents for all departments of WPPL Qualifications Required: - B.Pharm, M.Pharm, or M.Sc - 3-6 years of experience in Bioanalytical Quality Assurance for a BA/BE Study Please note that the job posting also provides information about Teva Pharmaceuticals' mission and its commitment to making good health more affordable and accessible worldwide.

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Teva Pharmaceuticals

Pharmaceutical Manufacturing

Tel-Aviv Petach Tikva

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Quality Analyst I